# K923367: Cosgrove Edwards Annuloplasty System, Model 4600

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jan 6, 1993 after 181 days
- Product code: KRH (Ring, Annuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020864: Edwards MC Tricuspid Annuloplasty System, Model 4900 (2002), 10 descendants of its own
- K103520: Carpentier-Edwards Physio Tricuspid Annuloplasty Ring (2011), 3 descendants of its own
- K032250: Geoform Annuloplasty Ring, Mitral Model 4200 (2003), 3 descendants of its own
- K163608: HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm (2017), 1 descendant of its own
- K033685: Northrup Universal Annuloplasty System, Model 1000 (2004), 1 descendant of its own

Source page: https://510kreport.com/device/K923367
Methodology: https://510kreport.com/methodology